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Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer

NCT01704027 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-09-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer

Conditions

Interventions

RADIATION

Simultaneous integrated boost intensity-modulated arctherapy

Three dose levels will be delivered at each fraction, 5 days a week, 30 fractions : * Pelvis : 55,5 Gy (1,85 Gy/fr) * Seminal vesicles : 66 Gy (2,2 Gy/fr) * Prostate : 72 Gy (2,4 Gy/fr)

DRUG

Androgen deprivation

Patients will received androgen deprivation for a maximum of three years. This treatment can start six months before radiotherapy and at least the day one of radiotherapy.

Sponsors & Collaborators

  • Centre Georges Francois Leclerc

    lead OTHER

Principal Investigators

  • Etienne MARTIN, MD · Centre Georges François Leclerc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01704027 on ClinicalTrials.gov